当前位置: 首页 > 详情页

Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

机构: [1]Department of Medical Oncology, Beijing KeyLaboratory of Clinical Study on Anticancer MolecularTargeted Drugs, National Cancer Center/NationalClinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences & Peking UnionMedical College, Beijing, People’s Republic of China [2]Department of General Thoracic Surgery, China-JapanFriendship Hospital, Beijing, People’s Republic of China [3]Department of Medical Oncology, Beijing Hospital,Beijing, People’s Republic of China [4]Beijing ChestHospital, Capital Medical University/BeijingTuberculosis and Thoracic Tumor Research Institute,Beijing, People’s Republic of China [5]Department ofOncology, The First Affiliated Hospital of Chinese PLAGeneral Hospital, Beijing, People’s Republic of China [6]Department of Oncology, Chinese PLA GeneralHospital, Beijing, People’s Republic of China [7]Department of Thoracic Surgery, The Fourth Hospitalof Hebei Medical University, Shijiazhuang, Hebei,People’s Republic of China [8]Department ofRespiratory Medicine, The Fourth Hospital of HebeiMedical University, Shijiazhuang, Hebei, People’sRepublic of China [9]Department of RespiratoryMedicine, Peking Union Medical College Hospital,Affiliated to Chinese Academy of Medical Sciences &Peking Union Medical College, Beijing, People’sRepublic of China [10]Department of Thoracic Surgery,Peking University People’s Hospital, Beijing, People’sRepublic of China [11]Department of Thoracic Surgery,Beijing Chaoyang Hospital Affiliated to Capital MedicalUniversity, Beijing, People’s Republic of China [12]Department of Radiotherapy and Chemotherapy,Tangshan People’s Hospital, Tangshan, Hebei, People’s Republic of China [13]Department of Thoracic Surgery,Xuanwu Hospital of Capital Medical University, Beijing,People’s Republic of China [14]Department of ThoracicSurgery, Peking University First Hospital, Beijing,People’s Republic of China
出处:
ISSN:

关键词: EGFR mutation non-small-cell lung cancer lung adenocarcinoma icotinib adjuvant chemotherapy

摘要:
The efficacy and possible role of epidermal growth factor receptor tyrosine kinase inhibitors in treating early-stage non-small-cell lung cancer have yet to be established. Therefore, we aimed to explore the efficacy and safety of icotinib in completely resected EGFR-mutant stage II-IIIA lung adenocarcinoma patients who underwent standard chemotherapy. This is a randomised, double-blinded, placebo-controlled, multicentre, Phase III trial. A total of 124 patients aged 18-75 years who qualified the inclusion criteria were recruited. These patients were randomised (1:1) to receive either icotinib (125 mg 3 times per day) or placebo (the same dosage and frequency) for 36 months, followed by a further 36 months of observational window. The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3- year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life. Analyses will be conducted in a full analysis set and a per-protocol set as well. To our knowledge, the present study is the first randomised, double-blinded, placebo-controlled, multicenter trial designed to explore efficacy and safety of icotonib in this population. The results obtained in the near future may provide potential guidance in clinical practice.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2019]版:
大类 | 3 区 医学
小类 | 3 区 肿瘤学
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 肿瘤学
JCR分区:
出版当年[2018]版:
Q3 ONCOLOGY
最新[2023]版:
Q3 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

第一作者:
第一作者机构: [1]Department of Medical Oncology, Beijing KeyLaboratory of Clinical Study on Anticancer MolecularTargeted Drugs, National Cancer Center/NationalClinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences & Peking UnionMedical College, Beijing, People’s Republic of China
通讯作者:
通讯机构: [*1]Department of Medical Oncology,Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, People’s Republic of China
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:16409 今日访问量:0 总访问量:869 更新日期:2025-01-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 首都医科大学宣武医院 技术支持:重庆聚合科技有限公司 地址:北京市西城区长椿街45号宣武医院